MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Overheating of Device (1437); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171)

Event Date 09/27/2015

Event Type  malfunction  

Manufacturer Narrative

Product id 37603, serial# (b)(4), implanted: 2013 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# va016ww, implanted: 2013 (b)(6); product type lead product id 3708640, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3387s-40, lot# va0611m, implanted: 2013 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension.(b)(4).

Event Description

A consumer reported the patient started experiencing new symptoms on 2015 (b)(6).The patient's chest started burning, tingling, and hurting.All morning, the patient's chest had been hurting and it had felt like shocking.The patient had been crying and sometimes it felt worse.The sensations were in the area of the implantable neurostimulator (ins).The burning, tingling, and pain in the chest occurred on 2015 (b)(6) and the shocking, pain, and tingling occurred on 2015 (b)(6).The patient had been referred to a pain management health care provider (hcp) by their deep brain stimulation (dbs) hcp.There was no trauma or falls related to the issue and there had been no recent medical tests or environmental exposure.The patient's indication for use is dystonia and movement disorders.No cause, interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the consumer reported there was burning and "popping" in her chest.The patient was having problems and uncomfortable feelings related to the device.The patient had grown from age 7 to age 9 since her implant and "that could make the leads not fit anymore".They felt like the wires were pulling and her chest hurt really bad on the morning of report.Additional information received from the health care professional (hcp) reported troubleshooting included skull and chest x-ray.No actions/interventions were taken.It was unknown what the cause of the tingling/burning/shocking/pain in the chest was.The patient had minor discomfort.

Manufacturer Narrative

(b)(4).

Event Description

A consumer later reported that the patient has been having headaches which had started around (b)(6) 2015 and had a sudden screaming headache on (b)(6) 2015.The patient had had dizziness and chest tightness where the stimulators were located.A healthcare professional told them to turn stimulation off.Following turning both stimulators off the headache had gone away within minutes.One stimulator was turned back on and the patient was still having dizziness.They had talked about changing out the batteries since the patient was still having problems.The cause was undetermined.Diagnostics included x-ray of hardware, seeing the neurosurgeon, interrogation of the integrity of the system.All was in working order and no abnormalities were detected.The patient was referred to the pain clinic.The patient's mother thought that these were not related to the stimulators.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5166401
• MDR Text Key: 29078794
• Report Number: 3004209178-2015-21162
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• Date Device Manufactured: 06/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00009 YR